BERLIN (Reuters) - German and British health officials issued conflicting messages on Friday about the health risk posed by breast implants made by a French company at the heart of a global health scare and whether they should be removed.
Germany’s Federal Office for Pharmaceuticals and Medical Devices advised women with implants made by Poly Implant Prothese (PIP) to have them taken out, saying reports from doctors had shown they might constitute a health risk.
However, following a review by its experts, Britain’s Department of Health said it had found no evidence to warrant the routine removal of the implants.
The conflicting government advice reflects a wider lack of international agreement over the regulation of medical devices, like implants, and the risks they pose.
The new head of Europe’s drugs watchdog told Reuters on Friday there was an acute need to tighten controls on medical devices. Guido Rasi, executive director of the European Medicines Agency (EMA) they needed the same level of regulation as medicines.
The scandal erupted when the French government advised 30,000 women to have PIP implants removed because of reports that the implants were more prone to rupturing than standard medical implants.
Concern focused on the death from cancer last year of a French woman with PIP implants.
About 300,000 PIP implants were sold worldwide before the firm went out of business in 2010 after an official investigation revealed it was using a cheaper unapproved industrial-grade silicone in some of its products.
Germany had advised women with implants to have them examined last month but it upped its warning after reports showed silicone could seep out without signs of tearing.
“The Office thus recommends that the implants in question be removed as a precautionary measure,” Walter Schwerdtfeger, President of the Federal Office for Pharmaceuticals and Medical Devices, said in a statement.
“The urgency for removal in each case depends mainly on how long the patients have had the implants.”
The UK expert review said it had found no link between the implants and cancer, but had not been able to establish if the PIP implants were more likely to rupture than others, saying information from the industry to the regulator was patchy.
“The data available to the experts has not been good enough to enable them to give a clear recommendation of the risk posed by PIP implants,” Health Secretary Andrew Lansley said in a statement.
But while Britain said there was no reason for the implants to be routinely removed, Lansley said patients who had received implants through the state-funded National Health Service (NHS) could have these removed and replaced by the NHS.
He added private health clinics were expected to provide the same service and Britain’s two largest private hospital providers, BMI Healthcare and Spire Healthcare, both said they would offer their patients free implant removal and replacement.
Anger with PIP was further fuelled on Friday when a police document was leaked to media which showed the company’s boss had admitted willfully lying about the implants’ poor quality and had accused women of filing complaints in return for money.
“I knew the gel was not standard but I did it consciously because the PIP gel was cheaper,” Jean-Claude Mas, the founder and chief executive of PIP is quoted as saying in a transcript of an interview with police in late 2010.
“This formula is perfect, it is better than the one used to make standard gel,” he said according to the document leaked in the French media and obtained by Reuters.
Lawyers representing women with PIP implants said Mas was treating their clients with disdain.
“Jean-Claude Mas is showing complete cynicism with regard to the victims,” said lawyer Laurent Gaudon, whose clients accuse PIP and surgeons who used the firm’s implants of fraud.